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GB 9706.16-2015: Medical electrical equipment -- Part 2: Particular requirements for the safety of radiotherapy simulators
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Medical electrical equipment -- Part 2: Particular requirements for the safety of radiotherapy simulators
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Basic data
Standard ID: GB 9706.16-2015 (GB9706.16-2015)
Description (Translated English): Medical electrical equipment -- Part 2: Particular requirements for the safety of radiotherapy simulators
Sector / Industry: National Standard
Classification of Chinese Standard: C43
Classification of International Standard: 11.040.60
Word Count Estimation: 31,343
Date of Issue: 2015-12-10
Date of Implementation: 2017-07-01
Older Standard (superseded by this standard): GB 9706.16-1999
Regulation (derived from): National Standard Announcement 2015 No.38
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
GB 9706.16-2015: Medical electrical equipment -- Part 2: Particular requirements for the safety of radiotherapy simulators
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical electrical equipment - Part 2. Particular requirements for the safety of radiotherapy simulators
ICS 11.040.60
C43
National Standards of People's Republic of China
Replacing GB 9706.16-1999
Medical electrical equipment -
Part 2. Radiation therapy simulation requirements for the safety
Part 2. Particularrequirementsforthesafetyofradiotherapysimulators
(IEC 60601-2-29.1999, IDT)
Issued on. 2015-12-10
2017-07-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Introduction Ⅲ
The first chapter outlines
1. Scope and purpose 1
2 Terms and definitions 2
5 Category 3
6 Identification, marking and documents 3
The second environmental conditions
10 environmental conditions 5
Third of the risk of electric shock protection
16 housing and protective cover 6
18 protective earthing, functional earthing and potential equalization 6
19 Continuous leakage currents and patient auxiliary current 6
Title IV of the mechanical hazards Protection
22 moving parts 7
27 pneumatic and hydraulic power 9
28 hangings 9
The fifth chapter of unwanted or excessive radiation hazard protection
29 X radiation 9
36 11 Electromagnetic Compatibility
Title VI of flammable anesthetic mixture ignition risk protection
Chapter 9. abnormal operation and fault conditions; Environmental Testing
52 abnormal operation and fault status 12
Publications Annex L (normative) References in this section involved --- 17
Annex AA (informative) Index 18 terms
Appendix BB (normative) References 26
101 sports equipment and define the axis scale --- 1 to 8, 9 to 13, the direction of rotation of the frame and size 14, 15 (adoption
IEC 60601-2-1) (see table) 13
And other sports equipment, and 102 define the axis scale --- 1,4 - 6,19, 9 to 12, 16 to 18, the direction and size 14, 15
Centre radiotherapy simulators or remote radiation therapy device (see table) 14
103 sports equipment from the radiation source and the scale --- observation of long-range radiation field radiation therapy or radiation therapy simulator community
Given radiation field (see table) 15
Specific Standard Table 101 should be noted in the accompanying documents, manual and technical specification, chapters and Article 5
Description Schedule equipment movement 16
Foreword
All technical content in this section is mandatory.
GB 9706 "Medical Electrical Equipment" safety standard series consists of two parts.
--- Part 1. General requirements for safety;
--- Part 2. Particular requirements for safety.
Wherein, Part 2. Particular requirements for safety include several parts, the Department is divided into Part 16 GB 9706.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This Part replaces GB 9706.16-1999 "Medical electrical equipment - Part 2. Radiation therapy simulation requirements for the safety", and
GB 9706.16-1999 compared to the main changes are as follows.
--- Remove the general requirements in Chapter 4, 1999 edition of the test;
--- Remove the 1999 edition 6.1 device or piece of equipment external marks;
--- Remove the controller and the 1999 edition 6.3 meter mark;
--- Increased provisions in 1999 indicating Version 6.3.101 scale and moving parts;
--- Version 6.8.2 adds 1999 Owner's Manual;
--- Remove the 1999 edition 10.1 transport and storage;
--- Remove the 1999 edition 10.2.1 environment;
--- 10.2.2 increased power;
--- Increasing the Chapter 16 case and protective cover;
--- Increased Chapter 18 protection grounding, grounding and potential equalization function;
--- Increased 19.3 permissible value;
--- Revised 19.1 General requirements;
--- Chapter 20 increased dielectric strength;
--- Remove the 1999 edition Chapter 21 mechanical strength;
--- Remove the 1999 version 22.4.101 or control device in an indoor simulator equipment parts operation;
--- Remove the 1999 version 22.4.102 be operated from the control simulator outdoor;
--- Remove the 1999 version 22.4.103 rack, radiation head, couch and X-ray image receiver electric operation requirements;
--- Increased 22.4 powered movement;
--- Increased 22.7.101 emergency stop the motor;
--- Revised Chapter 29 X-ray radiation;
--- An increase in chapter 36 Electromagnetic Compatibility;
--- Chapter 52 increased abnormal operation and fault conditions;
--- Remove the 1999 edition of the ninth and tenth articles articles.
This section identical with IEC 60601-2-29.1999 "Medical electrical equipment - Part 2. safety of radiotherapy simulators to
begging". Following editorial differences with the standard.
--- With a decimal point instead of a decimal point ",". ",";
--- According to GB/T 1.1-2009 for formatting has been modified;
--- Other international standards referenced standards, has been converted to our standards, this standard replaces other appropriate country by our standards
International standards;
--- Use the "standard" instead of the "special standard";
--- This standard removed IEC 60601-2-29.1999 Foreword and Introduction;
--- The standard terminology given in the fifth bold.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This part is proposed by the China Food and Drug Administration.
This part of the National Technical Committee of Standardization for medical appliances (SAC/TC10) centralized.
This section is drafted. Beijing Medical Device Testing.
The main drafters of this section. Wangpei Chen, Jiao spring camp, Miao Bin.
This section was first released in August 1999.
Medical electrical equipment -
Part 2. Radiation therapy simulation requirements for the safety
The first chapter outlines
1 Scope and purpose
1.1 Scope
increase.
GB 9706 this section applies to radiotherapy simulator.
--- The use of radiation therapy radiation beam diagnostic X-ray equipment simulate physical, can determine the therapeutic radiation field position and size, so that
Get treatment volume during treatment positionable illumination;
--- Used in radiation therapy before radiation therapy simulation purposes, not as a general diagnostic tests;
--- Technical specifications used in the specified environmental and power supply conditions;
--- Contains the following sections.
● a generation X-ray beam, the radiation beam radiation therapy is used to simulate the geometry of the system;
● can show an image of the X-ray beam system, e.g., X-ray radiography or X-ray;
● a control beam size and position, means for defining the intended treatment area;
● a way to simulate radiation therapy equipment geometry and mechanical support structure and movement of the imaging system;
● a control system;
● a treatment bed system.
1.2 Purpose
increase.
This defines the requirements for the safety and security of ionizing radiation to improve the mechanical and electrical safety simulator requirements, determine the radiation therapy
The key geometric parameters of precision simulation.
1.3 Specific Standard
increase.
1.3.101 relationship with the General Standard
Note. See Appendix L.
The specific standard take precedence over all other criteria, should be combined with the General Standard IEC 60601-1 corresponds to hereinafter as the universal standard
increase.
General Standard chapter or article if no corresponding chapter in this article specific standard, although may not be relevant, yet to be adopted modification
use. General standards related correspondence may still be adopted even though part of this standard will give specific instructions of its impact. Unless specifically
Door of generic standards shall apply to all.
And common standards, followed by the requirements of compliance testing. "This section" includes this specific standards and with common use
General Standard and Collateral Standard.
The specific standard chapter, article numbers and common standards, respectively. Changes to the General Standard text uses the following words to the provisions.
"Replace" means the General Standard chapter or article dedicated entirely replaced by the standard text.
"Increase" means the standard text dedicated to common standards go.
"Edit" means common standards chapter, in accordance with this article dedicated standard text to be modified.
General Standard added reg, figures and tables are numbered starting from 101, additional annexes to AA, BB, etc. number of items increased to aa),
bb) and other numbers.
1.3.102 relationships with other standards
a) IEC 60601-2-7
This standard applies to the radiotherapy simulator is equipped with diagnostic X-ray generator high voltage generator [see 29.1a)].
b) IEC 61217
This standard gives the movement device naming, design tick marks, zero position and increase the value of the direction of movement of the guidance [see
6.3.101a)].
1.5 Collateral Standard
increase.
1.5.101 IEC 60601-1-1
The collateral standard does not apply.
1.5.102 IEC 60601-1-2
The standard parallel bars in all chapters, and chapter 36 of the addition of provisions for radiation therapy simulators and information within the composition
Technology Equipment (ITE).
Note. IEC 60601-1-2 for medical device applications and ITE. Radiotherapy simulators and their components within ITE not exempt IEC 60601-1-2
Compliance requirements. The date of publication of this standard, it is not possible to decide whether it is necessary to make further revisions to the requirements and tests.
1.5.103 IEC 60601-1-3
In addition to Chapter 29 of the modification, the parallel standard all clauses apply.
1.5.104 IEC 60601-1-4
All of the standard parallel chapter shall apply [see 52.1b)].
2 Terms and definitions
increase.
NOTE. Appendix AA in alphabetical order, the terms and definitions given in all sources.
Increase the definition of terms used in this specific standard as follows.
2.1.101
Defining the radiation beam delineatedradiationbeam
Defining the radiation beam projector within the range.
2.1.102
Define the radiation field delineatedradiationfield
Define the radiation beam perpendicular to the beam axis of the radiation section plane on.
2.1.103
Definer delineator
Peripheral device used to simulate the radiation field boundaries.
2.1.104
Radiotherapy Simulator radiotherapysimulator
X-ray radiation therapy device emulation device geometry and motion of the radiation field, contribute to the treatment plan of a patient
Kind of equipment.
Category 5
replace.
Part equipment and its application shall be specified in Chapter 6, marking and (or) identification classification. include.
5.1 by anti-shock type.
--- Ⅰ class equipment.
According to the degree of protection against electric shock 5.2.
--- B type application part.
5.3 Under the existing IEC 60529 [see 6.1l)] in the degree of protection of the feed solution.
--- IPX0, unless otherwise specified.
5.4 By using the manual recommended disinfection or sterilization methods.
Security level at 5.5 by mixing with air or flammable anesthetic gases mixed with oxygen or nitrous oxide flammable anesthetic gases used in the case of.
--- Equipment is not suitable for use in flammable anesthetics mixed with air or gas mixed with oxygen or nitrous oxide flammable anesthetic gases situation.
5.6 Press Run mode.
--- Unless otherwise stated, suitable for standby and continuous power supply network, and adapted to a predetermined load.
6 Identification, marking and documentation
Control devices and 6.3 meter mark
increase.
6.3.101 scale indicating the provisions and moving parts
a) should provide.
--- Defining a predetermined number indicates the size of the radiation field on the distance;
--- Define the radiation beam and radiation field lighting instructions;
--- Indicating the location of such centers;
--- Indicates the focal distance of the methods of skin;
--- Image receptor in a patient or the incident surface of the reference axis indicating the position;
--- And defining the angular position of the radiation beam together, indicate to the operator of the simulated radiation therapy device may wedge filter direction;
--- Focus to digital video receiving an indication from the plane;
--- Focus to other digital instructions from the center, and when the distance is adjustable;
IEC 61217 --- in line with the agreed scale reading for indicating rack, head of radiation, beam limiting device, definer, video receivers
And exercise therapy bed [see 1.3.102b)].
b) When transmitting data between the simulators and other agreed scale radiation therapy equipment, to reduce the likelihood of the occurrence of errors, simulation
Machine can be equipped with additional scale to support other scale agreement, in which case the scale simulator display should not cause confusion.
By checking to verify compliance.
6.7 lights and buttons
a) LED Color
increase.
Color LEDs mounted on the treatment console (TCP) or any other console, should meet the following requirements.
--- Is illuminating yellow 1)
--- Readiness green 1)
--- Alarm and (or) a non-interrupt predetermined operating state needed urgent action red
--- Preset state other colors
1) In the simulator room or other places, these states may require urgent action or provide a warning in these spaces can be used "General requirements for safety" in Table 3
Specified color.
In the following cases, do not light emitting diodes (LEDs) as the light.
--- On any control panel, no special color requirements of all the instructions given in the same color LEDs; and
--- Indication of special color requirements are clearly identifiable.
6.8 random file
6.8.1 generous state
increase.
Note. random file includes manual and technical specification table 101 lists in this section relates to a random file chapter and article.
6.8.2 User's Guide
a) General information
increase.
Instructions should include.
--- All the features of radiation safety interlocks and other devices described;
--- Check the description of these devices to run properly;
--- Recommended frequency of required inspections;
--- When the normal use of equipment, interior equipment components with a safety function, when its dielectric and (or) the mechanical strength of ionizing radiation
When the impact of the recommended inspection or replacement cycle;
When given during parts list --- 4.10 humidity preconditioning tests may be affected by climatic conditions of equipment, as well as in the article
Listing under the member already tested parts.
j) environmental protection
increase.
--- Contains information to help users on Radiological Protection Consultants relevant data.
● define the scope of the availability of radiation field size;
● The distance to the focal point of the maximum available radiation field size and regulations;
● available radiation beam direction;
● X-ray source assembly/radiation mark the focal position of the head;
● The maximum available X-ray tube voltage.
6.8.3 Technical specification
a) Overview
increase.
Technical specifications should provide normal environmental conditions and power required for full details.
increase.
Specific Standard Table 101 should be noted in the accompanying documents, manual and technical specification Chapter Article
Note. "Check the reference number" only help access to relevant documentation.
Check the file reference number randomly Instructions Sheet
1 5.4
2 6.8.2a) and j)
3 6.8.3a)
4 16aa)
5 18b)
6 22.4.1a) 1) and a) 2)
7 22.4.1a) 4)
8 22.4.2e)
9 22.4.3e)
10 22.7.101
11 28.101b)
12 29.203.3
13 29.208.2
15 52.1b)
The second environmental conditions
Except as follows, "General requirements for safety" chapter in this Title, shall apply.
10 environmental conditions
increase.
Note. See 1.1, third column items, and 6.8.3a). increase.
10.2.2 Power
a) shall apply to the following power equipment.
The second column entry modified as follows.
--- Sufficiently low internal impedance, in order to prevent voltage fluctuations in load and standby mode more than ± 5%.
Third of the risk of electric shock protection
Except as follows, "General requirements for safety" chapter in this Title, shall apply.
16 housing and protective cover
increase.
aa) when all of this chapter or to determine when the installation should be provided in a random compliance check document Methods [See 57.1a)].
Through inspection and testing to verify whether the installation meets the requirements.
18 protective earthing, functional earthing and potential equalization
b) increase.
Technical specification shall contain recommendations for each installation and the local maximum fault current that may occur at the installation site connected devices
Protective ground terminal to the outside of the protection system permanently fixed protective earth conductor, in accordance with national regulations, should have a sufficiently large cross-sectional
area.
According to relevant national regulations [see 18f) and Regulation 6.5, Chapter 57 and Chapter 58 of Chapter], through inspection and testing to verify whether the installation breaks
Meets the requirement.
f) Replace.
Replace the first paragraph compliance testing with the following.
With 50Hz or 60Hz, no-load voltage not exceeding current source 6V, producing a 25A or 1.5 times the rated current, 2
Who take the smaller one (± 10%), within 5s ~ 10s time in protecting ground terminal and basic insulation failure may live under every
A flow between the metal parts can be touched before.
19 Continuous leakage currents and patient auxiliary current
19.1 General requirements
b) Replace.
At normal operating temperatures, typically permanently installed continuous power supply to a predetermined value of the leakage current and the leakage current of the casing, it is suitable for the following conditions
Any combination of elements.
--- Under normal conditions (NC) and a single fault condition (SFC) specified (see 19.2).
1) In the pre-state device, and under the most unfavorable possible combinations of simultaneously driven in a variety of movement, and
2) operating at maximum load.
In the normal operating condition and the above 1) and 2) provision, continuous earth leakage current and the leakage current measurement enclosure shall not exceed 19.3
Provisions.
19.3 permissible value
modify.
By the following content modification Table 4 Type B application part, normalcy.
Press Note 3) device earth leakage current of 20mA
Housing leakage current 0.5mA
Title IV of the mechanical hazards Protection
Except as follows, general requirements Benpian apply.
22 moving parts
replace.
22.4 powered motion (see Fig. 101, 102 and 103)
The treatment bed system, this requirement applies to the use of 135kg load and unload the mass of the object uniformly distributed.
Note 1. "Automatic settings" used to denote a piece of equipment automatically moves to the starting position of a patient in need of treatment simulation.
Note 2. The term "pre-programmed (control) movement" is used when the patient treatment simulation, according to the advance planning program-driven equipment, without operator intervention. Refer to "Pre
Programming therapy simulation. "
22.4.1 Rack, head of radiation, X-ray image receiver and couch
a) Overview
Note. Th......
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